FDA approves multiple sclerosis drug from Biogen and Alkermes

The Food and Drug Administration (FDA) has approved Vumerity (diroximel fumarate; Biogen) for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease..

Vumerity contains diroximel fumarate which rapidly converts to monomethyl fumarate in the body, the same active metabolite of dimethyl fumarate. The approval was based on bioavailability studies in patients with relapsing forms of multiple sclerosis and healthy individuals comparing oral dimethyl fumarate delayed-release capsules to Vumerity.

In addition, data from a phase 3, open-label, 2-year safety study (EVOLVE-MS-1) showed that treatment with diroximel fumarate was associated with low rates of gastrointestinal (GI) adverse events leading to discontinuation. In the EVOLVE-MS-2 trial, treatment with diroximel fumarate was found to be statistically superior to dimethyl fumarate, resulting in fewer self-reported days of GI symptoms..

Vumerity is contraindicated in patients currently taking dimethyl fumarate; it may be initiated the day following discontinuation of dimethyl fumarate.

The Company expects to make Vumerity available in the near future. The product will be supplied as 231mg strength delayed-release capsules in 106- and 120-count bottles.

For more information visit biogen.com.

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